NCT02112851

Processed Orange and the Glycemic Response

A Randomized, Placebo-controlled, Double-blind, Crossover Trial to Investigate the Effects of Acute Processed Whole Orange Consumption on Postprandial Glycemic Responses in Healthy Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 3 intervention arms, consisting of a control (Product A), a low dose processed whole orange (Product B) and a high dose processed whole orange (Product C), to determine the effect of the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma insulin concentrations will be quantified.

Detailed description

The study design is a randomized, placebo controlled, double-blind, crossover. This trial will include 33 subjects randomized to receive products A, B or C \[240 mL (255 g)\]. Subjects will be randomly assigned to one of 6 sequences of 3 interventions. After the initial screening visit, subjects will visit the Clinical and Translational Research Center (CTRC) the Tufts Translational and Clinical Science Institute (CTSI) on three separate occasions. Following each intervention day there will be a two week wash out period.

Conditions

• Maximum Observed Plasma Glucose Concentration (Cmax)

Interventions

Type	Name	Description
OTHER	Orange flavored beverage	Intervention involves consumption of one beverage of 240ml following baseline measurements

Timeline

• Start date: 2014-03-07
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-04-14
• Last updated: 2021-03-10

Locations

1 site across 1 country: United States